Surgical Technique Memory Staple

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1 Surgical Technique Memory Staple

2 Table of contents Introduction... 1 Features and Benefits... 1 Ordering Information Indications... 4 Contraindications... 4 Memory Staple Surgical Technique Calcaneal Step Staple Surgical Technique Common Procedures... 9

3 Introduction The Memory Staple is an ideal form of fixation for arthrodesis, osteotomy and fracture fixation. Manufactured from Nitinol, the BioPro Memory Staple offers continuous compression to help speed the fusion process. Nitinol is a shape memory alloy allowing the staple to offer active compression at the activation temperature of 98.6⁰F (37⁰C), patient body temperature. This eliminates the need for an external activation device while also offering benefits over pre-compressed staples such as more uniform compression. The S-Bend across the bridge of the BioPro Memory Staple ensures even compression across the fusion site, while maintaining a low profile against the bone. Features and Benefits The Memory Staple s unique activation method is complemented by simple, effective instrumentation that provide the surgeon with several intra-operative options for quick, reproducible results. Available in 17 standard sizes, plus six Step Staple options for calcaneal slides, the Memory Staple offers internal fixation with residual compression. The wide variety of sizes and styles make it ideal for most applications in the foot, ankle, hand and wrist. Compressed by patient body temperature S-bend in bridge offers compression across bridge 17 standard sizes 6 Step-staple sizes with offsets of 6mm, 9mm and 12mm Simple Instrumentation S-Bend Compressed at body temperature 1

4 Ordering Information The Memory Staple packaging is color coded for identification purposes. The header on the table below represents the color code on the staple packaging as well as on the corresponding instrumentation. Item # Description Size MEMORY STAPLE LARGE 20 x 20MM - 2 x 3MM MEMORY STAPLE LARGE 25 x 22MM - 2 x 3MM MEMORY STAPLE LARGE 30 x 30MM - 2 x 3MM Item # Description Size MEMORY STAPLE MEDIUM 15 x 12MM - 2 x 2MM MEMORY STAPLE MEDIUM 18 x 18 x 15MM - 2 x 2MM MEMORY STAPLE MEDIUM 20 x 20MM - 2 x 2MM Item # Description Size MEMORY STAPLE SMALL 7 x 5MM x 1.5MM MEMORY STAPLE SMALL 9 x 7MM x 1.5MM MEMORY STAPLE SMALL 11 x 8MM x 1.5MM MEMORY STAPLE SMALL 11 x 10MM x 1.5MM MEMORY STAPLE SMALL 13 x 10MM x 1.5MM MEMORY STAPLE SMALL 15 x 12MM x 1.5MM MEMORY STAPLE SMALL 11 x 15 x 13MM x 1.5MM MEMORY STAPLE SMALL 11 x 17 x 15MM x 1.5MM MEMORY STAPLE SMALL 11 x 19 x 17MM x 1.5MM Item # Description Size MEMORY STAPLE XSMALL 7 x 5MM x 1.2MM MEMORY STAPLE XSMALL 9 x 7MM x 1.2MM Item # Description Size STAPLE DRILL BIT XSMALL - 1.4MM STAPLE DRILL BIT SMALL - 1.8MM STAPLE DRILL BIT MEDIUM - 2.4MM STAPLE DRILL BIT LARGE - 3.0MM Item # Description Size STEP STAPLE 15 X 20MM - 6MM STEP STAPLE 15 X 20MM - 9MM STEP STAPLE 15 X 20MM - 12MM STEP STAPLE 20 X 20MM - 6MM STEP STAPLE 20 X 20MM - 9MM STEP STAPLE 20 X20 MM - 12MM Bridge width x Leg 1 x Leg 2 - Wire diameter Bridge width Leg 1 Leg 2 Wire diameter 2

5 Memory Staple Instrument Kit STAPLE KIT COMPONENTS (17707) Item # Description ADJUSTABLE DRILL GUIDE ANCHOR PIN SINGLE HOLE DRILL GUIDE ANGLED DRILL GUIDE 7-9MM ANGLED DRILL GUIDE 11-13MM ANGLED DRILL GUIDE 15-18MM SMALL STAPLE HEMOSTAT LARGE STAPLE HEMOSTAT LARGE STAPLE PUNCH SMALL STAPLE PUNCH ANGLED STAPLE PUNCH XSMALL STAPLE DRILL BIT - 1.4MM SMALL STAPLE DRILL BIT - 1.8MM MEDIUM STAPLE DRILL BIT - 2.4MM LARGE STAPLE DRILL BIT - 3.0MM INSTRUMENT TRAY 3

6 Indications Hand and foot bone fragment and osteotomy fixation and joint arthrodesis of the hand and foot bones. Fixation of soft tissue to bone such as anterior cruciate reconstruction Contraindications Comminuted bone surface which would militate against staple placement. Pathologic conditions of bone such as osteopenia which would impair the ability to securely fix the staple. Foreign body sensitivity to metals including nickel. Where material sensitivity is suspected, appropriate tests should be made prior to implantation. Important Note Any adjunctive procedures should be completed prior to staple implantation to avoid disrupting staple positioning. Immobilization, in addition to this internal fixation, until bone healing should be achieved by routine methods (casting, splints, etc.). Reduction of the site should be achieved and maintained prior to implanting the staple. The compressive force of the staple should not be relied upon to achieve closure or reduction of the fracture line. Care and Caution Inspect sterile pouches prior to use. Sterilization cannot be assured and staple should not be used if pouch or seal is damaged. Staples should be stored at 75ºF (24ºC) or less. Staples should be cooled to 75ºF (24ºC) prior to removing from the shipping block. Placing staples at -5ºF (-20ºC) will return staples to original position. The BioPro Memory Staples are a single use device. Do not autoclave staples. 4

7 Surgical Technique Fig. 1 The following technique demonstrates the use of the Memory Staple instrumentation. This technique can be applied to any procedure for successful implantation of the staple. Important Note: Always appose and temporarily fixate all bone fragments prior to drilling holes for staple implantation. Using the Adjustable Drill Guide Set the adjustable drill guide by pulling down on the set pin while sliding the guide bar until the desired staple size shows in the engraving window (Fig 1). Fig. 2 When using the adjustable drill guide, first drill the distal perpendicular hole, insert the anchor pin to stabilize the guide, then drill the proximal perpendicular hole. Fig. 3 Using the Single Hole and Angled Drill Guides To use the non-adjustable, angled drill guides start by drilling a perpendicular hole with the single hole drill guide (Fig 3). Fig. 4 Insert the pin on the end of the appropriately sized angled drill guide into the distal hole and coaptate the bone segments. Drill the proximal perpendicular hole using the angled drill guide (Fig 4). 5

8 Fig. 5 Staple Handling and Implantation Always use hemostats or the provided staple clamps to handle the BioPro Memory Staple. Warmth from a hand may prematurely activate the staple (Fig 5 & 6). Fig. 6 Fig. 7 Use the appropriate staple punch to ensure staples are fully inserted and seated against the bone (Fig 7). Fig. 8 After insertion, staples should sit flush against the bone. Staple compression will occur by body temperature, but may be hastened by irrigation with saline 98 F (37 C) to 100 F (38 C) (Fig 8). 6

9 Calcaneal Step Staple Technique Fig. 9 The following is a step-by-step technique for use of the BioPro Calcaneal Step Staple. Step One Calcaneal osteotomy is performed per surgeon s desired technique (Fig 9). Fig. 10 Step Two Choose the Step Staple Drill Guide for the appropriate width staple (either 15mm or 20mm). Place the center alignment pin within the osteotomy and ensure the handle is to the posterior side (Fig 10). Drill to a minimum depth of 20mm (all staple legs are 20mm long) through both drill guide holes. Repeat for second staple location. 7

10 Fig. 11 Step Three Determine desired medial displacement and choose the appropriately sized staple. Step staples are available in 6mm, 9mm and 12mm offsets. Remove the staple from the shipping block with the provided hemostats. Note: Always handle staples with hemostats. Heat from a hand may prematurely activate the staple. Step Four Insert the staple into the drill holes and impact flush to the surface of the calcaneous with the included impactors. Ensure that both surfaces of the calcaneous are flush with the stepped bridge design of the staple (Fig 11). Repeat the above procedure for the second staple (Fig 12). Fig. 12 Step Five Staple activation may be hastened by applying warm saline to the staple. 8

11 Common Procedures The BioPro Memory Staple can be used in a wide variety of fixation cases. Here are a few examples of possible procedures and correct staple placement. Hallux IP Fusion Hallux MPJ Fusion Lesser PIPJ Fusion Austin, Youngswick, Reverdin Bunionectomies Base Wedge Osteotomies Akin Osteotomies Cotton Procedure Lapidus Procedure Talonavicular Fusion Calcaneal Cuboid Fusion Dwyer Osteotomy 9

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